Trospium chloride once-daily extended release is efficacious and tolerated in elderly subjects (aged ≥75 years) with overactive bladder syndrome

What's known on the subject? and What does the study add? Treatment of overactive bladder syndrome (OAB) in elderly individuals presents several potential clinical challenges, which include alterations in sleep and cognition, multiple co-morbidities, polypharmacy, and frailty syndrome. A broad consensus of clinical opinion exists that the addition of an overactive bladder medication may amplify these clinical challenges via the antimuscarinic effects on cognition and the potential for drug-drug interactions. The quaternary amine structure of trospium chloride provides protection against penetration of the blood-brain barrier, and minimizes the potential for metabolic drug-drug interactions. This study globally supports the efficacy and safety of Sanctura XR (extended release trospium chloride) in a population of elderly patients (75 years or older) with overactive bladder syndrome and multiple co-morbidities at risk for drug-drug interactions, impaired cognition and frailty syndrome. OBJECTIVE To evaluate the safety and efficacy of once-daily trospium chloride extended release (ER) in overactive bladder syndrome (OAB) in subjects aged >= 75 years. SUBJECTS AND METHODS The analysis included subjects >= 75 years of age with OAB. A subgroup analysis of pooled data was performed for subjects aged >= 75 years from two randomized, double-blind, multicenter studies of subjects with OAB receiving once-daily trospium 60 mg extended release (ER) or placebo for 12 weeks, followed by 9-month open-label extension periods during which all subjects received trospium ER. A total of 143 of the 1165 subjects from two phase III registration trials who were aged >= 75 years (85 trospium ER, 58 placebo; mean age 79 years and ranging up to 90 years; 73% female) were evaluated. Dual primary efficacy variables were the changes from baseline in the average number of toilet voids per day and urge urinary incontinence episodes per day. RESULTS At week 12 of the double-blind period, trospium ER produced greater improvements from baseline than placebo in voiding diary parameters, OAB Patient Global Assessment, and quality of life. Efficacy and tolerability persisted among subjects receiving open-label trospium ER for up to 1 year. CONCLUSIONS Once-daily trospium chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged >= 75 years with OAB. For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year.